Depression, MS, Multiple Sclerosis
Conditions
Keywords
MS, Multiple Sclerosis, Depression, Depressed
Brief summary
The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.
Detailed description
MS-CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with Multiple Sclerosis) is a behaviorally informed, digital health, closed-loop-intervention that brings longitudinal mood reporting into the point of care. It consists of a simple tool used by the patient to improve mood reporting. This then triggers real-time alerts delivered to the clinician, who can access a comprehensive dashboard featuring risk factors and interventions to be considered, as well as resources local to the patient. This dashboard launches straight from the patient's electronic health record (EHR). MS-CATCH was designed using extensive human-centered design in all phases of development, and HIPAA compliant REDCap for electronic data capture. While the tool requires institutional approvals to launch within the UCSF EHR, the design elements could be readily repurposed using these technologies to support other institutions' requirements. Each individual care component and visualization was then developed and refined using extensive stakeholder engagement and an eye to the COM-B (Capability, Opportunity, and Motivation to change Behavior) principles of behavioral change, in order to promote behaviors likely to improve depression reporting, screening, comprehensive treatment and follow through.
Interventions
BEHAVIORALMS CATCH
Participants will respond to a set of surveys every month to increase communication on mood with their clinician.
Sponsors
University of California, San Francisco
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician will be blinded to what arm participants are a part of.
Intervention model description
Both arm 1 and arm 2 groups of participants will receive at least 6 months of MS CATCH tool intervention, with arm 1 receiving 12 months of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18 * Ages 18 to 80 * PHQ-9 score of 5-19 * Any MS therapy, or no treatment * California resident to enable clinical telemedicine visits if warranted during the study visit
Exclusion criteria
* Cognitive dexterity or visual impairment (typically defined as corrected acuity less than 20/70) that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to adhere to the study protocol * Inability to provide informed consent * Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder * Substance abuse that in the treating neurologist's perspective could influence the patient's safety on study or adherence to study protocol * Another co-morbid CNS diagnosis eg. TBI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood Screening - Primary | 0-6 months, 0-12 months | Clinician screening of depression as documented in the electronic health record (EHR) |
| Mood Reporting - Secondary | 6 months, Baseline, 12 months | The percentage of patients who self-report mood at each clinical visit |
| Comprehensive Mood Evaluation - Secondary | 0-6 months, 0-12 months | The percentage of depression risk factors evaluated at each clinical visit |
| Treatment recommendations - Secondary | 0-6 months, 0-12 months | The percentage of visits in which applicable care was recommended; number of preventative care recommendations |
| Treatment recommendation follow-through - Secondary | 0-6 months, 0-12 months | The number/percent of preventative care recommendations followed through by next visit |
| Adoption (uptake) - Primary | Initial month | The percentage of patients using the tool during the first month of the study |
| Adoption (uptake) - Secondary | Baseline, 6 months | The percentage of patient-clinician dyads who use the in-clinic dashboard at first visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood scores - Primary | Baseline, 3, 6, 9, and 12 months | Hospital Anxiety Depression Scale (HADS) will be measured at baseline, 3, 6, 9, and 12 months, scale: 0-21 range for depressive scale, and 0-21 range for anxiety scale, with higher score meaning more depressive or anxious symptoms |
| Mood scores - Exploratory | 12 months | Mini-International Neuropsychiatric Interview (MINI) assessment |
| Other self-reported outcome - Modified Fatigue Impact Scale - Exploratory | 0-12 months, 0-6 months, 6-12 months | Evaluating possible contributors to mood: fatigue (MFIS), scale: 0-84, higher score indicates more impact |
| Other self-reported outcome - Pittsburgh Sleep Quality Index - Exploratory | 0-12 months, 0-6 months, 6-12 months | Evaluating possible contributors to mood: sleep (PSQI), scale: 0-21, higher scores indicates worse sleep quality |
| Other self-reported outcome - Oxford-Participation and Activities Questionnaire - Exploratory | 0-12 months, 0-6 months, 6-12 months | Evaluating possible contributors to mood: engagement (Ox-PAQ), scale: 0-100, higher score indicates more problems with activity and participation |
| Other self-reported outcome - Impact on Participation and Autonomy - Exploratory | 0-12 months, 0-6 months, 6-12 months | Evaluating possible contributors to mood: participation (IPA), scale: 0-128, with higher score indicating more impact on a person's autonomy and participation |
| Engagment (Sustained use) - Secondary | Every 3 months | The percentage of patients who continue to use the patient-facing tool at least quarterly |
| Engagement (Sustained use) - Secondary | 12 months | The percentage of patient-clinician dyads in Arm 1 (early start) who continued to use the tool at the 12 month visit |
| Engagement (Sustained use) - Exploratory | Baseline, 6 month, 12 month | Length of each session |
| Engagement (Sustained use) - Exploratoy | 12 month | Qualitative feedback in exit interviews |
| Adherence - Secondary | 12 months | The percentage of depression-reporting prompts responded to per participant on their patient-facing tool; the percentage participants responding to \>75% depression prompts |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRiley Bove, MD
University of California, San Francisco
Outcome results
None listed